A level A in vitro/in vivo correlation in fasted and fed states using different methods: Applied to solid immediate release oral dosage form

Souliman, Sabah; Blanquet, S.; Beyssac, Eric; Cardot, Jean‐Michel

doi:10.1016/j.ejps.2005.08.006

Cited by 112 publications

(81 citation statements)

References 12 publications

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“…For conventional drug and nutritional compounds, TIM-1 has been extensively used to characterize their bioaccessibility from food and beverage product matrices, expressed as a percentage intake, under various physiological conditions and transit times along the GI tract (Blanquet et al, 2004). The profiles are highly consistent with preclinical jejunal data in both fasted and fed states (Souliman et al, 2006). However, the use of a dialysis membrane to provide an absorptive surface does not model active cellular transport.…”

Section: In Vitro Non-cellular Fluid Modelssupporting

confidence: 49%

Utility of models of the gastrointestinal tract for assessment of the digestion and absorption of engineered nanomaterials released from food matrices

Venema²,

et al. 2014

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Engineered metal/mineral, lipid and biochemical macromolecule nanomaterials (NMs) have potential applications in food. Methodologies for the assessment of NM digestion and bioavailability in the gastrointestinal tract are nascent and require refinement. A working group was tasked by the International Life Sciences Institute NanoRelease Food Additive project to review existing models of the gastrointestinal tract in health and disease, and the utility of these models for the assessment of the uptake of NMs intended for food. Gastrointestinal digestion and absorption could be addressed in a tiered approach using in silico computational models, in vitro non-cellular fluid systems and in vitro cell culture models, after which the necessity of ex vivo organ culture and in vivo animal studies can be considered. Examples of NM quantification in gastrointestinal tract fluids and tissues are emerging; however, few standardized analytical techniques are available. Coupling of these techniques to gastrointestinal models, along with further standardization, will further strengthen methodologies for risk assessment.

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Section: In Vitro Non-cellular Fluid Modelssupporting

confidence: 49%

Utility of models of the gastrointestinal tract for assessment of the digestion and absorption of engineered nanomaterials released from food matrices

Venema²,

et al. 2014

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“…However,this type of system,even if it could be used in drug development with success (19,22,23),is not a quality control tool due to its complexity.…”

Section: In Vitro Apparatusmentioning

confidence: 99%

In Vitro–In Vivo Correlation: Importance of Dissolution in IVIVC

Cardot

Beyssac²,

Alric³

2007

Dissolution Technol.

116

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“…This machine is also capable of processing homogenised meals and a duodenal compartment can also be added to the experimental process allowing this model to be a so far, unsurpassed artificial model of the stomach [65,[153][154][155]. Several authors have also used a multi-compartmental artificial GI system known as the TIM-1 which was developed by the TNO Nutrition and Food Research Centre in Zeist, The Netherlands, to try and establish a more accurate prediction of in vivo performance [156][157][158][159]. The TIM-1 consists of four interconnected compartments of the stomach, duodenum, jejunum and ileum that allow the simulation of the GI tract [65].…”

Section: Numerous Other In-vitromentioning

confidence: 99%

Drug release from matrix tablets: physiological parameters and the effect of food

Nokhodchi

Asare-Addo

2014

Expert Opinion on Drug Delivery

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Introduction: As dissolution plays an important and vital role in the drug-delivery process of oral solid dosage forms, it is, therefore, essential to critically evaluate the parameters that can affect this process. Areas covered:The consumption of food as well as the physiological environment and properties of the gastrointestinal tract, such as its volume and composition of fluid, the fluid hydrodynamics, properties of the intestinal membrane, drug dose and solubility, pK a , diffusion coefficient, permeability and particle size, all affect drug dissolution and absorption rate. There are several dissolution approaches that have been developed to address the conditions as experienced in the in vivo environment, as the traditional dissolution being a quality control method is not biorelevant and as such do not always produce meaningful data. This review also describes the development of a systematic way that differentiates between robust and non-robust formulations by varying the effects of agitation and ionic strength through the use of the automated United States Pharmacopeia type III Bio-Dis apparatus. Expert opinion:With the improved understanding of the physiological parameters that can affect the oral bioperformance of dosage forms, strides have, therefore, been made in making dissolution testing methods more bio-logically based with the view of obtaining more in vitro--in vivo correlations.Keywords: agitation rate, biodissolution, drug release, effect of food, hydrophilic matrices, ionic strength Highlights -Understanding all the physiological parameters can serve as a basis for designing dissolution testing methods and systems that can more fully represent the gastrointestinal (GI) tract in humans and allow more in vitro-in vivo (IVIVC) correlations to be obtained thereby improving the oral bioperformance of dosage forms.-Simulation of GI conditions is essential to adequately predict the in vivo behaviour of drug formulations.-The choice of appropriate media for in vitro tests is crucial to their ability to correctly forecast the food effect in pharmacokinetic studies.-Several methods of dissolution testing have been conducted and are still ongoing that seek to further understand and develop media and dissolution methods to better represent the in vivo conditions and to aid in the better prediction of in vivo drug release.-Systematic change of agitation method and ionic strength evaluation may be used as additional tools in allowing for the identification of potential fed and fasted effects on drug release from hydrophilic matrices in the drive for developing dissolution methodologies that are more relevant in helping to achieve more IVIVC.

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A level A in vitro/in vivo correlation in fasted and fed states using different methods: Applied to solid immediate release oral dosage form

Cited by 112 publications

References 12 publications

Utility of models of the gastrointestinal tract for assessment of the digestion and absorption of engineered nanomaterials released from food matrices

Utility of models of the gastrointestinal tract for assessment of the digestion and absorption of engineered nanomaterials released from food matrices

In Vitro–In Vivo Correlation: Importance of Dissolution in IVIVC

Drug release from matrix tablets: physiological parameters and the effect of food

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